Novel Biomarker Identification. Rapid Risk Assessment.

The innovative end result of Astute Medical’s novel biomarker identification, the NephroCheck® Test provides risk assessment of critically ill patients who may develop acute kidney injury. A single-use cartridge designed to detect biomarkers of acute kidney injury (AKI), the NephroCheck® Test is available for use with the Astute140® Meter. By producing results in approximately 20 minutes, the test aids clinicians in making more rapid responses for critically ill patients.

The diagnosis of AKI is still made on the basis of a change in serum creatinine or urine output, both of which are derived from an altered glomerular filtration which identifies dysfunction not damage. Dysfunction only becomes evident when more than 50% of the renal mass is compromised and implies that it may be a later phenomenon in the time course of an AKI. Unlike these surrogates, the NephroCheck® Test identifies actual renal stress, before damage or dysfunction has occurred.

The test consists of two novel biomarkers, TIMP-2 and IGFBP-7, which alert the clinician of ongoing kidney cellular stress before kidney dysfunction becomes apparent. TIMP-2 and IGFBP-7 both are involved in G1 cell cycle arrest during the very early phases of cellular stress and are robust measures of risk for AKI manifesting within the next 12-24 hours.

TIMP-2 (Tissue Inhibitor of MetalloProteinases-2)

Inhibitor of the matrix metalloproteinases (MMPs)1

Directly suppresses the proliferation of endothelial cells2-5

Implicated in epithelial cell-cycle arrest6-9

IGFBP-7 (Insulin-like Growth Factor Binding Protein-7)

Regulation of tissue availability of insulin and IGFs10-14

Stimulates cell adhesion15-17

Implicated in epithelial cell-cycle arrest18

TIMP-2 and IGFBP-7 used in the NephroCheck Test® have been found to provide superior clinical utility which equip the medical community with an unprecedented and valuable tool for early risk assessment of AKI in critically ill patients.

Novel Biomarker Detection Process

After the user inserts the NephroCheck® Test cartridge, the Astute140® Meter converts the fluorescent signals for the individual immunoassays—the specific novel biomarkers—into concentrations, combining them into a single numerical test result. The NephroCheck® Test and Astute140™ Meter employ a sandwich immunoassay technique along with fluorescence detection technology to quantitatively measure biomarkers of acute kidney injury in human urine samples. Multiple levels of controls (internal, external and electronic) ensure reliable and accurate test results.

Intended Use

The NephroCheck Test® result is intended as an aid in the risk assessment of acute kidney injury in the critically ill. The NephroCheck® Test results should be evaluated in the context of all clinical and laboratory data available.